Head of Quality & Regulatory Affairs

We are Specto Medical, a medical software company building immersive visualization tools for medical imaging data. Our flagship product, Specto, lets surgeons and clinicians inspect CT and MRI scans in mixed and virtual reality, giving instant spatial understanding of patient anatomy. Specto is FDA-cleared and CE-marked, and our eQMS is ISO 13485 certified.

Following a successful Series A we are building Specto 2, the next generation of our spatial computing platform, and a portfolio of AI-enabled quantitative clinical information services for nuerosurgical planning.

You will be taking over quality and regulatory affairs across the company, maintaining and improving our existing eQMS with senior part-time support. You will be incorporating AI guidances and regulations and will GMLP a lean approach to quality management as we embed and automate quality artifacts and deliverables into our product development and operational processes. Furthermore, you will be instrumental in defining our product portfolio regulatory strategy while working alongside the engineering, ML, and clinical team.

• Evolve our eQMS (ISO 13485, FDA QMSR) so that it scales to an AI product line
• Lead risk management (ISO 14971, including AI-specific i), software lifecycle (IEC 62304), usability engineering (IEC 62366-1), and cybersecurity documentation
• Keep the design history file and technical documentation current and audit-ready for Notified Body audits, FDA inspections, and customer due diligence
• Partner with the engineering team to translate medical device regulations into practical R&D guidance

• Define the pathway strategy for the AI portfolio
• Lead our FDA and Notified Body relationships
• Author and drive submissions (e.g. 510(k) and MDR conformity assessment)
• Build our EU AI Act position for high-risk AI and pre-authorized envelope for model retraining and updates (PCCP)

• Define the evidence strategy with our ML and clinical leads
• Responsible for PMS and PMCF including vigilance, complaint handling, real-world performance monitoring, and periodic reporting

• Demonstrated experience with FDA 510(k) clearance of Class II SaMD
• Excellence in assembling and negotiating the MDR technical documentation assessment through a Notified Body for Class IIa/IIb software
• Deep understanding of the SaMD standards stack: ISO 13485, ISO 14971, IEC 62304, IEC 62366-1
• Readiness to lead the implementation of the EU AI Act high-risk conformity for medical AI into our eQMS
• Ability to navigate regulatory ambiguity in undecided pathways, novel claims, or in absence of clean precedents
• Hands-on familiarity with modern software engineering practices
• Proficient written and spoken English
• Existing right to work in the EU or Switzerland
• ML literacy and experience with clearance and certification of SaMDs with AI/ML features
• Neuroimaging or neuro-oncology domain experience
• Experience in the surgical-planning / navigation regulatory landscape as well as diagnostic radiology SaMD
• Familiarity with GMLP and with real-world performance monitoring for deployed AI models
• Data protection in a clinical context (GDPR, HIPAA) and multi-site clinical data agreements

• A leadership role reporting directly to the CEO
• Regulatory work with bleeding-edge spatial computing and novel AI technology
• Competitive salary, Swiss social security and pension benefits
• Employee stock option plan
• Primary workplace is Basel, Switzerland, with flexible working hours and home office arrangements
• The opportunity to build software with real clinical impact for surgeons and patients